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Comparison of Genes in Healthy Women, Women at High Risk for Breast Cancer, and Women With Breast Cancer

This study has been suspended.

Sponsors and Collaborators: NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00023608
  Purpose

RATIONALE: Genetic testing for specific genes that are associated with estrogen may help identify patients who are at greatest risk for developing breast cancer.

PURPOSE: This clinical trial is studying genetic differences in healthy women, women at high risk for breast cancer, and women who have breast cancer.


Condition Intervention
Breast Cancer
Procedure: cytogenetic analysis
Procedure: gene expression profiling
Procedure: gene mapping
Procedure: polymorphic microsatellite marker analysis

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Susceptibility to Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Risk of breast cancer associated with polymorphisms in genes involved in estrogen metabolism and action as measured by personal health history, cancer family history , risk factor history, food frequency questionnaire, and blood sample at study entry [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk biomarkers as measured by nipple aspirate collection at study entry [ Designated as safety issue: No ]
  • Correlate breast density and polymorphisms in genes associated with estrogen metabolism and action as measured by mammogram at study entry [ Designated as safety issue: No ]

Estimated Enrollment:   3000
Study Start Date:   June 2001
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

  • Determine the risk of breast cancer associated with polymorphisms in genes involved in estrogen metabolism and action.
  • Determine the relationship between susceptibility genotypes and environmental risk factors for each tumor type.
  • Determine the biomarkers of breast cancer risk and/or early detection in nipple fluid, blood, and tissues.
  • Determine whether breast density and polymorphisms in genes are associated with estrogen metabolism and action.

OUTLINE: Participants donate a blood sample and complete an epidemiological, dietary, and family history questionnaire. Participants who have undergone biopsy or surgery for breast cancer are asked to authorize the use of their tissues.

Participants who have had a routine film screen mammogram within the past year are asked to submit their most recent mammogram for breast density determination.

Participants warm their breasts with a warm moist washcloth over approximately 30 minutes, then undergo nipple fluid aspiration over 15 seconds, up to 5 times per breast. Women who have any active infection or superficial inflammation of the breast or who are currently lactating or less than 6 months post-lactation do not undergo nipple fluid sampling.

Restriction fragment length polymorphism analysis, simple tandem repeat polymorphism analysis, automated fluorescent genotyping, and single-stranded conformation polymorphism analysis are used to test for genes associated with the biosynthesis and metabolism of estrogen (COMT1, CYP1A1, CYP1A2, CYP2D6, CYP2E1, CYP3A4, CYP17, CYP19, EPHX1, EPHX2, NAT1, NAT2, NQO1, AHR, UDPGT, GSTA1, GSTA2, GSTA3, GSTM1, GSTM2, GSTM3, GSTM5, GSTP1, GSTT1, GSTT2, GSTX1, and GSTX2).

Two-dimensional gel electrophoresis, laser capture microdissection, and surface-enhanced laser desorption ionization spectroscopy are used to test for vitamin D receptor and members of the homocysteine/methionine metabolism family, methylenetetrahydrofolate reductase, methionine synthase, and cystathione beta synthase in nipple fluid, blood, and tissue.

Participants do not receive the results of the genetic testing and these results are not kept in their medical records.

PROJECTED ACCRUAL: A total of 3,000 women (1,000 healthy, 1,000 at high risk for breast cancer, and 1,000 with breast cancer) will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

DISEASE CHARACTERISTICS:

  • Meets the criteria for one of the following groups:

    • Documented history of invasive breast cancer
    • Documented history of ductal carcinoma in situ
    • Normal health (control group), meeting all of the following criteria:

      • No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
      • Pedigree Assessment Tool (PAT) score < 8
      • Gail risk < 1.67
    • High risk for breast cancer, meeting the following criteria:

      • No prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix AND meeting at least 1 of the following criteria:

        • Estimated risk of developing breast cancer over the next 5 years > 1.66 by the Gail Model
        • Documented deleterious mutation in BRCA1 or BRCA2
        • PAT score ≥ 8
        • History of lobular carcinoma in situ
        • History of atypical lobular or ductal hyperplasia
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Adult

Sex:

  • Female

Menopausal status:

  • Pre- or postmenopausal

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023608

Locations
United States, Maryland
National Naval Medical Center    
      Bethesda, Maryland, United States, 20889-5600
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators
NCI - Center for Cancer Research-Medical Oncology
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Giuseppe Giaccone, MD, PhD     NCI - Medical Oncology Branch    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068814, NCI-00-C-0079
First Received:   September 13, 2001
Last Updated:   October 18, 2008
ClinicalTrials.gov Identifier:   NCT00023608
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer  
stage II breast cancer  
stage IV breast cancer  
stage IIIA breast cancer  
stage IIIB breast cancer
stage IIIC breast cancer
ductal breast carcinoma in situ
lobular breast carcinoma in situ

Study placed in the following topic categories:
Carcinoma, Lobular
Skin Diseases
Disease Susceptibility
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Healthy
Genetic Predisposition to Disease
Breast Diseases
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 30, 2008




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